Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original HDE to get an up-to-date view of this device. |
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Trade Name | Spiration Valve System |
Classification Name | one-way air-leak valve |
Generic Name | one-way air-leak valve |
Applicant |
Gyrus ACMI, Inc. |
6675 185th avenue ne |
redmond, WA 98052 |
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HDE Number | H060002 |
Supplement Number | S012 |
Date Received | 11/14/2019 |
Decision Date | 08/19/2020 |
Product Code | |
Advisory Committee |
Anesthesiology |
Supplement Type | normal 75 day track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Change to eli grade nitinol as raw material for spiration valve frames. |
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